Celldemic

Opinion

EMA has issued an opinion on this medicine

influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

Overview

On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Celldemic, intended for active immunisation against the H5N1 subtype of Influenza A virus in adults and infants from 6 months of age and above.

The applicant for this medicinal product is Seqirus Netherlands B.V..

Celldemic will be available as a 7.5 micrograms per 0.5 ml dose suspension for injection. Celldemic is an influenza vaccine (ATC code J07BB02). It contains haemagglutinin and neuraminidase surface antigens purified from inactivated A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG 23) viruses produced in MDCK cell cultures and the adjuvant M59C.1. The Celldemic vaccine triggers an immune response against the H5N1 subtype of the influenza A virus.

The benefit of Celldemic is a robust immune response in adults and children three weeks after two doses of the vaccine given three weeks appart, as measured by haemagglutination inhibition titres against H5N1. The most common side effects in adults are pain at the injection site, fatigue, headache, malaise, myalgia and arthralgia. In children aged between 6 and 18 years, the most common side effects are injection site pain, myalgia, fatigue, malaise, headache, loss of appetite, nausea, and arthralgia. In children 6 months to less than 6 years of age, the most common side effects are tenderness at the injection site, irritability, sleepiness, change in eating habits and fever.

The full indication is:

Celldemic is indicated for active immunisation against H5N1 subtype of Influenza A virus in adults and infants from 6 months of age and above.

Celldemic should be used in accordance with official recommendations.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Celldemic

AdoptedReference Number: EMA/71755/2024

Product details

• Name of medicine:
  Celldemic
• Active substance:
  Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen
• International non-proprietary name (INN) or common name:
  influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
• Therapeutic area (MeSH):
  Influenza, Human
• Anatomical therapeutic chemical (ATC) code:
  J07BB02
• EMA product number:
  EMEA/H/C/006052
• Marketing authorisation applicant:
  Seqirus Netherlands B.V.
• Opinion adopted:
  22/02/2024
• Opinion status:
  Positive